Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 16-26, 28-34, and 36-38 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Amendments to the Claims and Remarks filed on 11/11/2025.
Claims 16-26, 28-29, and 31-33 are currently amended.
Claims 27, 35, and 39 are cancelled.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 38 is recited to comprise a computer-readable storage medium having various features that, under the broadest reasonable interpretation, may be entirely embodied in transitory forms of signal transmission. Claim 38 is rejected because it does not sufficiently recite a non-transitory computer readable storage medium. The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. §101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. §101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. §101 by adding the limitation "non-transitory" to the claim. Cf. Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. §101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998). In furtherance of compact prosecution, Examiner will further consider the claims under 35 USC § 101 as if the claims were amended to be directed towards a non-transitory computer-readable medium and not signal per se.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-19, 23-26, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Moskal et al.( US-20200351376-A1)[hereinafter Moskal], in view of Sehgal (US-20140266713-A1)[hereinafter Sehgal].
As per Claim 16, Moskal discloses a medical system in paragraphs [0019] (a system for collecting infusion data) comprising: a medical device comprising an input/output operating unit that receives a system control command from a user in paragraphs [0019] and [0062] and [0064] (an infusion pump includes a input/output device that collects pump programming data, wherein programming data includes user key presses (synonymous to a system control command from a user)); a remote data processing unit comprising an input unit, wherein medical device- individualized information is enterable into the input unit in paragraphs [0021] and [0023] (a server computer , referred to as a server (synonymous to the remote data processing unit), includes a user interface (synonymous to an input unit), wherein a data set (synonymous to medical device-individualized information) is enterable into the user interface); and a data connection connecting the medical device and the remote data processing unit in paragraphs [0020] and [0024] (a network interface circuit (synonymous to a data connection) connecting the infusion pump and the server computer), wherein the medical device is actuatable by the remote data processing unit via the data connection based on the medical device-individualized information input into the input unit in paragraphs [0012] [0021] and [0023] (the infusion pump (synonymous to a medical device) is actuatable by a server (synonymous to the remote data processing unit) based on the data set input into the user interface), wherein the remote data processing unit is actuatable by the system control command entered into the input/output operating unit of the medical device and that is transmitted to the remote data processing unit via the data connection in paragraphs [0012-0013] and [0020] (the server is actuatable by the command entered into the input/output device of the infusion pump and is transmitted to the server via the network interface circuit), and wherein the system control command causes the remote data processing unit to perform an action in paragraphs [0012] and [0029] (wherein the user key presses causes the server computer to perform an action).
Moskal discloses a system control command causing an action being performed, but does not disclose one of the actions being automatically switching off, locking, or initiating repair or maintenance of the medical device. However, Sehgal discloses wherein the system control command causes the remote data processing unit to perform an action including at least one of automatically switching off, locking, or initiating repair and/or maintenance of the medical device in paragraphs [0030] and [0045] (the data server (synonymous to remote data processing unit) automatically turns off or renders the medical device as inoperable).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal, to be combined with the system control command causing an action of automatically switching off, locking, or initiating repair or maintenance of the medical device, as disclosed by Sehgal, for the purpose of reducing significant costs to a hospital [0005].
As per Claim 17, Moskal and Sehgal disclose the medical system according to claim 16, Moskal also discloses wherein medical device- individualized information, which is entered into the remote data processing unit and is transmitted to the medical device, is displayed on the input/output operating unit in paragraphs [0021] and [0023] and [0045] and [0064] and Figure 2 (the data set which is entered into the server computer and is transmitted to the infusion pump is displayed on the input/output device).
As per Claim 18, Moskal and Sehgal disclose the medical system according to claim 16, Moskal also discloses wherein the medical device-individualized information, which is entered into the input unit of the remote data processing unit, is device-specific information, via which the medical device is selected from a plurality of medical devices in paragraphs [0020] and [0024] and [0048] (the data set entered into the user interface of the server computer is device-specific information, via the infusion pump selected from a plurality of infusion pumps).
As per Claim 19, Moskal and Sehgal disclose the medical system according to claim 18, Moskal also discloses wherein the device-specific information is at least one of a device ID, a model number, or a serial number in paragraphs [0048] (the device-specific information includes a serial number).
As per Claim 23, Moskal and Sehgal disclose the medical system according to claim 16, Moskal also discloses wherein the input/output operating unit further receives medical device state information which depicts a current state of the medical device in paragraphs [0036-0037] and [0047] (receive infusion pump connection status (synonymous to medical device state information) which indicates the current connection status of the infusion pump), and wherein the medical device state information is transmittable to the remote data processing unit via the data connection and the medical device state information, once transmitted, causes the action at the remote data processing unit in paragraphs [0020] and [0026] and [0036-0038] (the infusion pump connection status is transmittable to the server computer via the network interface circuit and the infusion pump connection status causes an action at the server).
As per Claim 24, Moskal and Sehgal disclose the medical system according to claim 23, Moskal also discloses wherein the medical device state information is comprises defect information relating to a defect of the medical device in paragraphs [0036] (the dataset programming error (synonymous to defect information) indicates an error occurred in the infusion pump).
As per Claim 25, Moskal and Sehgal disclose the medical system according to claim 23.
Moskal discloses medical device state information, but does not disclose the medical device state information including an indication that the medical device needs to be serviced. However, Sehgal discloses wherein the medical device state information comprises an indication that the medical device needs to be serviced in paragraphs [0028] and [0038] (the medical device's activity (synonymous to the medical device state information) includes an indication that the medical device needs maintenance (Examiner notes that the medical device's activity indicates the status of the medical device)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal, to be combined with the medical device state information includes an indication that the medical device needs to be serviced, as disclosed by Sehgal, for the purpose of reducing significant costs to a hospital [0005].
As per Claim 26, Moskal and Sehgal disclose the medical system according to claim 23, Moskal also discloses wherein the medical device state information transmitted to the remote data processing unit is displayable at the remote data processing unit in paragraphs [0047] (the infusion pump connection status transmitted to the server computer is displayed at the user interface of the server computer).
As per Claim 28, Moskal and Sehgal disclose the medical system according to claim 16.
Moskal does not disclose the following limitations. However, Sehgal discloses wherein the input/output operating unit of the medical device is comprises a touch screen and inputs of a user on the touch screen cause the action at the remote data processing unit in paragraphs [0030] and [0045] and [0056] and [0058] (the input device of the medical device is a touch screen and user inputs cause the action at the data server).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal, to be combined with the input/output operating unit of the medical device includes a touch screen and inputs into the touchscreen causes an action at the remote data processing unit, as disclosed by Sehgal, for the purpose of reducing significant costs to a hospital [0005].
As per Claim 30, Moskal and Sehgal disclose the medical system according to claim 16, Moskal also discloses wherein the medical device is a syringe or infusion pump in paragraphs [0019] (an infusion pump).
As per Claim 31, Moskal and Sehgal disclose the medical system according to claim 16, Moskal also discloses wherein the remote data processing unit is a cloud server in paragraphs [0024] (the server computer is a cloud server).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Moskal et al.( US-20200351376-A1)[hereinafter Moskal], in view of Sehgal (US-20140266713-A1)[hereinafter Sehgal], in view of LEDFORD et al. (US-20180126067-A1)[hereinafter Ledford].
As per Claim 20, Moskal and Sehgal disclose the medical system according to claim 18, Moskal also discloses wherein the remote data processing unit comprises a databank in paragraphs [0020] and [0042] (the server computer includes a database (synonymous to a databank)).
Moskal and Sehgal do not disclose the following limitations. However, Ledford discloses wherein the device-specific information is assigned to a specific medical device in the databank in paragraphs [0058] and [0060] and [0068] (individual pump identification is assigned to a specific type of infusion pump), and wherein the remote data processing unit is adapted to detect the medical device and to transmit recognition information to the selected medical device based on the entered device-specific information in paragraphs [0058] and [0060] and [0070] and [0091] (the selected medical device outputs a guidance or identification information (synonymous to a designation) via the user interface (synonymous to the input/output operating unit) of the medical device).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal and Sehgal, to be combined with assigning device-specific information to a specific medical device in the database and detect the medical device and transmit recognition information to the selected medical device based on the entered device-specific information, as disclosed by Ledford, for the purpose of reducing practitioner workloads, inefficiencies, and potential dangers [0002-0006].
Claims 21-22 is rejected under 35 U.S.C. 103 as being unpatentable over Moskal et al.( US-20200351376-A1)[hereinafter Moskal], in view of Sehgal (US-20140266713-A1)[hereinafter Sehgal], in view of LEDFORD et al. (US-20180126067-A1)[hereinafter Ledford], in view of CHEN et al. (US-20230215555-A1)[hereinafter Chen].
As per Claim 21, Moskal, Sehgal, and Ledford disclose the medical system according to claim 20.
The combination of Moskal, Sehgal, and Ledford does not disclose the following limitations. However, Chen discloses wherein the selected medical device is actuatable by the remote data processing unit in such a way that the selected medical device outputs a designation via the input/output operating unit in paragraph [0039] (the guidance includes a step-by-step walk through (synonymous to graphic information) displayed on the user interface).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal, Sehgal, and Ledford, to be combined with the selected medical device outputting a designation via the input/output operating unit, as disclosed by Chen, for the purpose of providing a more efficient and effective maintenance solution for medical devices [0004].
As per Claim 22, Moskal, Sehgal, and Ledford disclose the medical system according to claim 21.
The combination of Moskal, Sehgal, and Ledford does not disclose the following limitations. However, Chen discloses wherein the designation is at least one of a flashing of the input/output operating unit, graphic information being displayed on the input/output operating unit, or a colored margin around a pop-up field displayed on the input/output operating unit in paragraphs [0039] (the guidance includes a step-by-step walk through (synonymous to graphic information) displayed on the user interface).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal, Sehgal, and Ledford, to be combined with the designation being a flash, graphic displayed, or a colored margin around a pop-up field displayed, as disclosed by Chen, for the purpose of providing a more efficient and effective maintenance solution for medical devices [0004].
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Moskal et al.( US-20200351376-A1)[hereinafter Moskal], in view of Sehgal (US-20140266713-A1)[hereinafter Sehgal], in view of ASAMA (JP-2005342099-A)[hereinafter Asama].
As per Claim 29, Moskal and Sehgal disclose the medical system according to claim 16.
Moskal and Sehgal do not disclose the following limitations. However, Asama discloses further comprising a carrier system into which a plurality of medical devices is insertable and wherein the carrier system comprises the remote data processing unit in paragraphs [0001-0002] and [0005] and [0010] and [0018] (the medical system includes a medical carrier (synonymous to a medical system) into which a plurality of medical devices is insertable and the medical carrier includes a communication unit (synonymous to a data processing unit)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical system, as disclosed by Moskal and Sehgal, to be combined with a carrier system, as disclosed by Asama, for the purpose of making the attachment/detachment operation easy, safe, and reliable [0004].
Claims 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over LEDFORD et al.( US-20180126067-A1)[hereinafter Ledford], in view of CHEN (US-20230215555-A1)[hereinafter Chen].
As per Claim 32, Ledford discloses a medical designation method for selecting and operating a medical device from a plurality of medical devices, each of which is connected to a remote data processing unit via a data connection in paragraphs [0007] and [0047] and [0052] and [0058] and Figure 3 (A coordinating and controlling method for selecting and operating a infusion pump from a plurality of infusion pumps, each of which are coupled to the embedded server via a network), the medical designation method comprising the steps of: receiving device-specific information in an input unit of the remote data processing unit in paragraphs [0058] and [0067] and [0121] (receiving individual pump identification (synonymous to device-specific information) input device of the embedded server (synonymous to the remote data processing unit)); selecting the medical device by the remote data processing unit from the plurality of medical devices based on the device-specific information in paragraphs [0058] and [0060] and [0070] (selecting the infusion pump by the embedded server from the plurality of infusion pumps based on the individual pump identification); and driving the selected medical device by the remote data processing unit via the data connection in paragraphs [0060] and [0070] (driving the selected infusion pump by the embedded server via network).
Ledford does not disclose the following limitations. However, Chen discloses, whereby an operating unit of the selected medical device outputs a user-perceivable designation making, the selected medical device recognizable in the plurality of medical devices in paragraph [0039] (the selected medical device outputs a guidance or identification information (synonymous to a user-perceivable designation) making it recognizable in the plurality of medical devices).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical designation method for selecting and operating a medical device from a plurality of medical devices, as disclosed by Ledford, to be combined with the selected medical device outputting user-perceivable designation making the selected medical device recognizable, as disclosed by Chen, for the purpose of providing a more efficient and effective maintenance solution for medical devices [0004].
As per Claim 34, Ledford and Chen disclose the steps of the medical designation method according to claim 32. Ledford also discloses a computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to perform the steps of the medical designation method according to claim 32 in paragraphs [0048-0050] (a non-volatile memory include instructions, when executed by a processor, cause the processor to perform the steps of coordinating and controlling method).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over LEDFORD et al.( US-20180126067-A1)[hereinafter Ledford], in view of CHEN (US-20230215555-A1)[hereinafter Chen], in view of Medema (US-20040155772-A1)[hereinafter Medema].
As per Claim 33, Ledford and Chen disclose the medical designation method according to claim 32.
Ledford and Chen do not disclose the following limitations. However, Medema discloses wherein the user-perceivable designation is at least one of an optical, acoustic, or haptic signal, a flashing of a screen of the operating unit, beeping of the selected medical device, or vibration of the selected medical device in paragraph [0050] and claims 46 and 57 (the remote locating service produces an audible or visual alarm signal to identify the selected medical device).
It would have been obvious to one of ordinary still in the art to include in the a medical designation method for selecting and operating a medical device from a plurality of medical devices of Ledford and Chen with the user-perceivable designation including at least an optical, acoustic, or haptic signal as taught by Medema since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably a medical designation method that outputs an audible or visual alarm as a user-perceivable designation.
Claim 36-38 is rejected under 35 U.S.C. 103 as being unpatentable over Sehgal (US-20140266713-A1)[hereinafter Sehgal], in view of CHEN (US-20230215555-A1)[hereinafter Chen].
As per Claim 36, Sehgal discloses a medical notification method for a medical device in paragraphs [0006] and [0028] (an alert (synonymous to a medical notification) method for a medical device) comprising the steps of: receiving defect information of a medical device on which a defect has occurred in paragraphs [0028] and [0042-0045] (receiving maintenance parameter values (synonymous to defect information) from of a medical device on which maintenance should be performed (Examiner notes that maintenance parameter values indicate if a defect has occurred of the medical device)); transmitting the defect information from the medical device to a remote data processing unit via a data connection in paragraphs [0030] and [0047] (transmitting the maintenance parameter values from the medical device to the data server (synonymous to a remote data processing unit) via a network (synonymous to a data connection)); and automatically triggering corrective maintenance of the medical device at the remote data processing unit based on the defect information in paragraphs [0006] and [0045-0047] (alerting the clinician for performing maintenance of the medical device at the data server based on the maintenance parameter values (Examiner notes that the specification of the claimed invention discloses notifying a technician to repair the medical device is an example of automatically triggering corrective maintenance)).
Sehgal discloses receiving defect information of a medical device which the defect has occurred, but does not disclose the defect information coming from an user. However, Chen discloses receiving defect information from a user into an input/output operating unit of a medical device on which a defect has occurred in paragraphs [0042] and [0062] and Figure 5 (initiating a scan for maintainable events (synonymous to receiving defect information) from the user interface device (synonymous to an input/output operating unit) of the medical device in maintenance mode (Examiner notes that the user interface prompts to user to press a key to scan the medical device for maintenance events in maintenance mode indicating receiving defect information from a user on a medical device that needs maintenance or has a defect)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention for a medical notification method for a medical device, as disclosed by Sehgal, to be combined with receiving defect information from a user into an input/output operating unit of a medical device which a defect has occurred, as disclosed by Chen, for the purpose of providing a more efficient and effective maintenance solution for medical devices [0004].
As per Claim 37, Sehgal and Chen disclose the medical notification method according to claim 36, Sehgal also discloses wherein the corrective maintenance at the remote data processing unit comprises at least one of initiating a repair of the medical device when a defect in the medical device has been detected or locking the medical device in paragraphs [0028] and [0030] and [0045] (the data server (synonymous to remote data processing unit) automatically turns off or renders the medical device as inoperable until the maintenance is performed when maintenance parameters values exceed a maintenance threshold value (synonymous to when a defect in the medical device has been detected) (Examiner notes that turning off or rendering the medical device as inoperable until maintenance is performed indicates initiating the maintenance or repair of the medical device)).
As per Claim 38, Sehgal and Chen disclose the steps of the medical notification, Sehgal also discloses a computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to perform the steps of the medical notification method according to claim 36 in paragraphs [0006] and [0028] and [0057] (a machine-readable medium including instructions, executed by a processor, cause the processor to perform the steps of an alert method for a medical device).
Response to Arguments
Applicant's arguments, see Pages 8-10, “Claim Rejections – 35 U.S.C. 101” filed 11/11/2025 with respect to claims 16, 32, and 36 have been fully considered and are persuasive. However, Claim 38 is rejected under 35 U.S.C. 101 due to computer-readable storage medium limitation having various features, under the broadest reasonable interpretation, may be entirely embodied in transitory forms of signal transmission.
Applicant’s arguments, see Pages 10-13, “Claim Rejections - 35 US.C. 102(a)(1)” and “Claim Rejections - 35 U.S.C. 103”, filed 11/11/2025 with respect to claims 16-39 have been considered. With regards to claims 16-28 and 30-39, Applicant argues that Mills does not describe the amended limitations of the independent claims. Examiner finds this persuasive. Therefore, the rejection of 09/02/2025 has been withdrawn. However, upon further consideration a new grounds of rejection is made over Moskal in view of Sehgal. As per the rejection of claim 29, Applicant argues that Asama does not further describe the features of amended claim 16. Examiner points Applicant to the updated rejection and citations in the 103 rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bourget, Philippe, “Design and Development of a User-Friendly Motorized Apparatus for the Filing of Portable Infusion Pumps by Hospital and Homecare Health Workers” (2016) teaches a motorized apparatus to fill infusion pumps.
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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682